Quality Assurance Senior Representative

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

In this role, you will provide general quality assurance/systems support and leadership to our Menlo Park site. Activities include releasing batch records, overseeing testing, creating CMAs, Environmental Monitoring work, etc. We are seeking a candidate with clinical-stage QA background in drug substance biologics manufacturing (e.g. antibodies, proteins, reagents), at the supervisor/manager level, and a strong desire to learn.

Key Responsibilities

• As an on-site team of one, oversee the quality assurance activities at the Menlo Park site.
• Conduct batch releases and manage quality control testing.
• Ensure compliance with clinical stage manufacturing requirements, with a preference for experience in antibody or large molecule manufacturing.
• Work closely with manufacturing, CMC and science teams on quality assurance tasks.
• Participate in tech transfer from clinical production to commercial production within the next 1-2 years.
• Collaborate with all staff to support consistent production at the Menlo Park site.
• Implement and manage documentation and quality control procedures, updating obsolete procedures as necessary.
• Contribute to the development of in-house raw material production, ensuring the facility meets regulatory and quality standards.
• Contribute to the setup and management of a quality system for pipeline products, ensuring high standards for clinical manufacturing.

Desired Qualifications

• Proven experience (5+ years) in quality assurance, ideally within clinical-stage manufacturing for a biotech company.
• Familiarity with antibody manufacturing is highly desirable.
• Strong self-motivation and ability to work with minimal oversight.
• Excellent communication skills to work effectively with cross-functional teams.

Who we are

We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.

We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.

We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.

We maintain a start-up culture of camaraderie and leadership by example, regardless of title.

We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.

To learn more: https://orcabio.com/join-our-team/